RE:ANOTHER COVID-19 HOME TEST.. available Research and Development $$.this will be a major issue at THRM. just so you know that this isn't a strait forward process...
Manufacturing Scale-Up
Ellume has been able to fast-track the development of its range of COVID-19 diagnostic tests with the support of a$30 million WP-2 grant from the U.S. National Institutes of Health (NIH)’s Rapid Acceleration of Diagnostics (RADx) initiative.
In order to meet anticipated demand, Ellume has expanded its manufacturing facility in Brisbane, Australia, the largest of its kind in the Southern Hemisphere, and is rapidly expanding its manufacturing efforts and supply chain within the U.S. Production has already commenced and Ellume will be shipping over 100,000 tests per day from next month. Ellume plans to manufacture and deliver 20 million Ellume COVID-19 Home Tests to the U.S. within the first half of 2021.
The Ellume COVID-19 Home Test is an over-the-counter, rapid self-test which detects SARS-CoV-2 antigen. The test is suitable for ages 2+ years and will be available for non-prescription use in the U.S*. It enables individuals, with and without symptoms, to test for COVID-19 infection in 15 minutes, anywhere.
Utilizing the dedicated App, users follow step-by-step instructions to perform the test including a self-collected mid-turbinate swab. The sample is analyzed and results are automatically transmitted to the user’s smartphone via Bluetooth®. Results can be shared with healthcare professionals to enable optimal therapy.
Through a secure, HIPAA compliant cloud connection, the Ellume COVID-19 Home Test provides real-time reporting of results and critical patient data to health authorities, employers and educators, for efficient COVID-19 mapping.
In U.S. – For use under Emergency Use Authorization (EUA) The Ellume COVID-19 Home Test correctly identified 96% of positive samples and 100% of negative samples in individuals with symptoms. In people without symptoms, the test correctly identified 91% of positive samples and 96% of negative samples.
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